Pelvic Organ ProlapsePhase 3CLNUPNCT04048356
Chlorhexidine vs. Iodine for Vaginal Preparation in Urogynecologic Procedures
A Phase 3 study testing Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery. in people with Pelvic Organ Prolapse and Urinary Incontinence, run by University of New Mexico at 1 site in United States.
Trial summary
This is a randomized controlled trial to determine if there is a difference between chlorhexidine gluconate and povidone iodine vaginal preparations for urogynecological surgery post operative infections. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Organ Prolapse, Urinary Incontinence, Pelvic Floor Disorders
- What is being tested?
- Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2019to 14 Mar 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female Subjects >18 years of age
- English or Spanish speaking/reading
- Must be able to provide informed consent
- Undergoing urogynecologic procedures or surgery
Who cannot join
- Pregnant - all patients are verified regarding pregnancy status prior to gynecologic surgical intervention at all sites of surgery - for patients who are premenopausal and have a uterus, a urine pregnancy test is administered in the preoperative setting. Pregnancy status is also determined prior to this in the office setting by interview and patient provided history prior to offering surgery to the patient.
- Inability to return for follow-up visits
- No concurrent need for vaginal antisepsis, such as cases of sacral neuromodulation
- Lack of telephone
- Known allergy to either antiseptic agent
- Prisoners will not be eligible to participate in this study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, 87106
About this study
Official title: Chlorhexidine Gluconate Versus Povidone Iodine for Vaginal Surgical Preparation for Urogynecological Procedures
This is a randomized controlled trial to determine if there is a difference between chlorhexidine gluconate and povidone iodine vaginal preparations for urogynecological surgery post operative infections.
Read the detailed description
The purpose of this randomized controlled trial is to determine whether there is a difference in efficacy of two of the most common commercially available vaginal surgical preparations. The first objective is to determine whether chlorhexidine gluconate is non-inferior to povidone iodine with respect to post-operative infections including urinary tract infections (both culture proven and empirically treated) and surgical site infections (as defined by the Centers for Disease Control). The second objective is to determine whether chlorhexidine gluconate is non-inferior to povidone iodine with respect to vulvar and vaginal irritation.
- Conditions
- Pelvic Organ Prolapse, Urinary Incontinence, Pelvic Floor Disorders, Gynecologic Disease, Post-Op Infection, Surgical Site Infection
- Being tested
- Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.
- Keywords
- Urogynecology, Surgery, Antiseptic Preparation
- Medical subject headings
- Pelvic Organ Prolapse, Urinary Incontinence, Pelvic Floor Disorders, Genital Diseases, Female, Surgical Wound Infection, Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.Drug
Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.
| Study group | Role | What they receive |
|---|---|---|
| Chlorhexidine gluconate | Experimental | Chlorhexidine gluconate 2% vaginal scrub, to be applied vaginally and perineally immediately prior to surgery. Receives: Drug: Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery. |
| Povidone Iodine | Active comparator | Povidone iodine vaginal scrub, to be applied vaginally and perineally immediately prior to surgery. Receives: Drug: Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Urinary Tract Infection
Urinary tract infection as defined by positive urine culture of >10,000 cfu, or empirically treated symptoms.
Measured: 2 weeks post operatively
Secondary outcomes (2)
Rate of Surgical Site Infection
Surgical site infection as defined by CDC guidelines: https://www.cdc.gov/nhsn/pdfs/pscmanual/9pscssicurrent.pdf
Measured: 14 days postoperatively
Vaginal Irritation
Vaginal irritation (including specific symptoms of discomfort, burning, or itching) based on a 5-point scale (Likert type, from 0 minimum/better to 5 maximum/worse, total score reported))
Measured: Post operative day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2019
- Study start15 Jul 2019
- Primary completion28 Feb 2021
- Study completion14 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karen Taylor, BA, Study director, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04048356
- Sponsor's protocol ID
- 19-039
- Acronym
- CLNUP
- Status last verified
- Jun 2023
- First submitted
- 2 Aug 2019
- Last updated
- 10 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rockefeller NF, Petersen TR, Komesu YM, Meriwether K, Dunivan G, Ninivaggio C, Jeppson PC. Chlorhexidine gluconate vs povidone-iodine vaginal antisepsis for urogynecologic surgery: a randomized controlled noninferiority trial. Am J Obstet Gynecol. 2022 Jul;227(1):66.e1-66.e9. doi: 10.1016/j.ajog.2021.12.260. Epub 2021 Dec 29.
PubMed 34973179
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chlorhexidine Gluconate Versus Povidone Iodine for Vaginal Surgical Preparation for Urogynecological Procedures
- ClinicalTrials.gov ID
- NCT04048356
- Acronym / sponsor ID
- CLNUP / 19-039
- Conditions
- Pelvic Organ Prolapse, Urinary Incontinence, Pelvic Floor Disorders, Gynecologic Disease, Post-Op Infection, Surgical Site Infection
- Keywords
- Urogynecology, Surgery, Antiseptic Preparation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Study start
- 15 Jul 2019 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 14 Mar 2021 (actual)
- First posted
- 7 Aug 2019 (actual)
- Results
- Posted 10 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized controlled trial to determine if there is a difference between chlorhexidine gluconate and povidone iodine vaginal preparations for urogynecological surgery post operative infections.
Detailed description
The purpose of this randomized controlled trial is to determine whether there is a difference in efficacy of two of the most common commercially available vaginal surgical preparations. The first objective is to determine whether chlorhexidine gluconate is non-inferior to povidone iodine with respect to post-operative infections including urinary tract infections (both culture proven and empirically treated) and surgical site infections (as defined by the Centers for Disease Control). The second objective is to determine whether chlorhexidine gluconate is non-inferior to povidone iodine with respect to vulvar and vaginal irritation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chlorhexidine gluconate | Experimental | Drug: Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.Chlorhexidine gluconate 2% vaginal scrub, to be applied vaginally and perineally immediately prior to surgery. |
| Povidone Iodine | Active comparator | Drug: Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.Povidone iodine vaginal scrub, to be applied vaginally and perineally immediately prior to surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female Subjects >18 years of age
- English or Spanish speaking/reading
- Must be able to provide informed consent
- Undergoing urogynecologic procedures or surgery
Key exclusion criteria (6 listed)
- Pregnant - all patients are verified regarding pregnancy status prior to gynecologic surgical intervention at all sites of surgery - for patients who are premenopausal and have a uterus, a urine pregnancy test is administered in the preoperative setting. Pregnancy status is also determined prior to this in the office setting by interview and patient provided history prior to offering surgery to the patient.
- Inability to return for follow-up visits
- No concurrent need for vaginal antisepsis, such as cases of sacral neuromodulation
- Lack of telephone
- Known allergy to either antiseptic agent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery. | Drug | Chlorhexidine gluconate, Povidone Iodine |
Primary outcome
Rate of Urinary Tract Infection
Time frame: 2 weeks post operatively
Urinary tract infection as defined by positive urine culture of >10,000 cfu, or empirically treated symptoms.
2 secondary outcomes
Rate of Surgical Site Infection
Time frame: 14 days postoperatively
Vaginal Irritation
Time frame: Post operative day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34973179Rockefeller NF, Petersen TR, Komesu YM, Meriwether K, Dunivan G, Ninivaggio C, Jeppson PC. Chlorhexidine gluconate vs povidone-iodine vaginal antisepsis for urogynecologic surgery: a randomized controlled noninferiority trial. Am J Obstet Gynecol. 2022 Jul;227(1):66.e1-66.e9. doi: 10.1016/j.ajog.2021.12.260. Epub 2021 Dec 29.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Taylor, BA study director
University of New Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery. in people with Pelvic Organ Prolapse and Urinary Incontinence, run by University of New Mexico at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Urinary Tract Infection (time frame: 2 weeks post operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04048356, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2023.